Gene Expression During Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Choline Magnesium Trisalicylate

NCT ID: NCT00156299

Last Updated: 2013-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2008-07-31

Brief Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in cancer cells. It may also help doctors understand how cancer cells respond to treatment with choline magnesium trisalicylate.

PURPOSE: This pilot clinical trial is studying gene expression in cancer cells during chemotherapy and the safety of choline magnesium trisalicylate in treating patients with newly diagnosed acute myeloid leukemia.

Detailed Description

OBJECTIVES:

Primary

• Determine temporal changes in leukemic cell NF-kB activity when choline magnesium trisalicylate is administered during induction chemotherapy in patients with newly diagnosed acute myeloid leukemia.
• Determine toxicities of this regimen in these patients.

Secondary

• Determine patterns of leukemic cell gene expression in patients treated with this regimen.
• Determine if NF-kB modulation results in enhanced apoptosis in patients treated with this regimen.

OUTLINE: This is an open-label, pilot study.

Patients receive oral choline magnesium trisalicylate every 8 hours for 48 hours or dexamethasone every 6 hours for 48 hours plus choline magnesium trisalicylate every 8 hours for 48 hours during induction chemotherapy as determined by the primary physician.

Blood is collected at baseline, 24 hours, and 48 hours to assess for changes in NF-kB expression, apoptosis, and gene expression in leukemic cells.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Conditions

Leukemia

Keywords

adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myelomonocytic leukemia (M4); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); untreated adult acute myeloid leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dexamethasone plus Choline Magnesium Trisalicylate

Dexamethasone plus Choline Magnesium Trisalicylate

Group Type: EXPERIMENTAL

choline magnesium trisalicylate

Intervention Type: DRUG

1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48.

Dexamethasone

Intervention Type: DRUG

10mg orally every 6 hours beginning at hour 0 and continuing until hour 48.

Choline Magnesium Trisalicylate

Choline Magnesium Trisalicylate

Group Type: EXPERIMENTAL

choline magnesium trisalicylate

Intervention Type: DRUG

1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48.

Interventions

choline magnesium trisalicylate

1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48.

Intervention Type: DRUG

Dexamethasone

10mg orally every 6 hours beginning at hour 0 and continuing until hour 48.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed acute myeloid leukemia

• Newly diagnosed disease
• Presence of cytogenetic abnormalities must be determined by standard cytogenetics with or without FISH studies
• Leukemic blast count > 5,000/mm³ of peripheral blood
• No acute promyelocytic leukemia (M3)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-3
• Bilirubin < 2.0 times upper limit of normal (ULN)
• AST < 3.0 times ULN
• Creatinine < 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No uncontrolled psychiatric illness that, in the opinion of the principal investigator, would preclude study compliance
• No other concurrent medical condition that would preclude study compliance
• No allergies to any investigational drugs and/or chemotherapeutic agents
• No upper or lower gastrointestinal (GI) related hemorrhage within the past 6 months as determined by endoscopy

• No clinical diagnosis of GI bleeding requiring blood transfusions

PRIOR CONCURRENT THERAPY:

• No prior induction therapy
• No prior chemotherapy for acute leukemia
• No concurrent medications that would preclude study compliance

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Strair, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Countries

United States

References

Strair RK, Gharibo M, Schaar D, Rubin A, Harrison J, Aisner J, Lin HC, Lin Y, Goodell L, Anand M, Balsara B, Dudek L, Rabson A, Medina DJ. Nuclear factor-kappaB modulation in patients undergoing induction chemotherapy for acute myelogenous leukemia. Clin Cancer Res. 2008 Nov 15;14(22):7564-8. doi: 10.1158/1078-0432.CCR-08-1390.

Reference Type: RESULT

PMID: 19010875 (View on PubMed)

Other Identifiers

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

020201

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000540303

Identifier Type: -

Identifier Source: org_study_id